BEUDAMED
    FDA Enforcement Class II Terminated

    Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree.

    Recall: Z-1862-2013 · Reported August 7, 2013

    Enforcement

    Recall Number
    Z-1862-2013
    Event ID
    64625
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Acclarent, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 7, 2013
    Initiation Date
    January 11, 2013
    Classification Date
    August 1, 2013
    Termination Date
    October 25, 2013
    Address
    1525-B O'Brien Dr, N/A, Menlo Park, CA, 94025-1463, United States

    Description

    Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree.

    Reason

    Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some instructional steps.

    Code Info

    Product code: BC8524A; All lots manufactured after March 1, 2011

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, and Saudi Arabia.

    Quantity

    625